ABBREVIATED PRESCRIBING INFORMATION
Please refer to the Summary of Product Characteristics (SmPC) before prescribing
Sandostatin LAR (octreotide) 10mg, 20mg and 30mg powder and solvent for suspension for injection.
Presentation: One powder vial containing 10, 20 or 30 mg octreotide (as octreotide acetate). Prefilled syringe containing solvent co-packaged in a tray with vial adapter and safety injection needle.
Indications: Treatment of patients with acromegaly in whom surgery is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective. Treatment of patients with symptoms associated with functional gastro entero pancreatic (GEP) endocrine tumours. Treatment of patients with advanced neuroendocrine tumours of the midgut or of unknown primary origin where non-midgut sites of origin have been excluded. Treatment of TSH secreting pituitary adenomas: when secretion has not normalised after surgery and/or radiotherapy; or in patients in whom surgery is inappropriate; or in irradiated patients, until radiotherapy is effective.
Dosage and Administration: Sandostatin LAR may only be administered by deep intramuscular injection. The site of repeat intramuscular injections should be alternated between the left and right gluteal muscle.
Acromegaly:
Initial administration of 20 mg Sandostatin LAR every 4-weeks for 3 months. Adjust dosage based on assessment of GH and IGF-1 levels and clinical symptoms. If clinical symptoms and biochemical parameters (GH; IGF 1) are not fully controlled within this 3 month period (GH concentrations still above 2.5 mcg/L), the dose may be increased to 30 mg every 4 weeks. If after 3 months, GH, IGF 1, and/or symptoms are not adequately controlled at a dose of 30 mg, the dose may be increased to 40 mg every 4 weeks. For patients whose GH concentrations are consistently below 1 mcg/L, whose IGF 1 serum concentrations normalised, and in whom most reversible signs/symptoms of acromegaly have disappeared after 3 months of treatment with 20 mg, 10 mg Sandostatin LAR may be administered every 4 weeks. Close monitoring of adequate control of serum GH and IGF 1 concentrations, and clinical signs/symptoms is recommended at this low dose of Sandostatin LAR. For patients on a stable dose of Sandostatin LAR, GH and IGF 1 should be assessed every 6 months.
GEP endocrine tumours
Patients with symptoms associated with functional GEP neuroendocrine tumours
Initial administration of 20 mg Sandostatin LAR at 4-week intervals. Patients on treatment with s.c. Sandostatin should continue at the previously effective dosage for 2 weeks after the first injection of Sandostatin LAR. Where symptoms and biological markers are well controlled after 3 months of treatment, dose may be reduced to 10 mg Sandostatin LAR every 4 weeks. Where symptoms are only partially controlled after 3 months of treatment, dose may be increased to 30 mg Sandostatin LAR every 4 weeks. For days when symptoms associated with GEP tumours may increase during treatment with Sandostatin LAR, additional administration of s.c. Sandostatin is recommended at the dose used prior to the Sandostatin LAR treatment. This may occur mainly in the first 2 months of treatment until therapeutic concentrations of octreotide are reached.
Treatment of patients with advanced neuroendocrine tumours of the midgut or of unknown primary origin where non-midgut sites of origin have been excluded
Recommended dose is 30 mg administered every 4 weeks. Treatment with Sandostatin LAR for tumour control should be continued in the absence of tumour progression.
Treatment of TSH-secreting adenomas
Initial dose of 20 mg at 4-weekly intervals for 3 months before considering dose adjustment. The dose is then adjusted on the basis of the TSH and thyroid hormone response.
Patients with impaired renal function: no dose adjustment necessary. Patients with impaired hepatic function: in certain cases patients with impaired hepatic function may require dose adjustment. Use in the elderly: no dose adjustment necessary. Children: experience is limited.
Contraindications: Hypersensitivity to octreotide or any of the excipients.
Warnings/Precautions: General: All patients with GH secreting pituitary tumours must be carefully monitored in case complications occur with tumour expansion (e.g. visual field defects). Fertility could be restored in female acromegalic patients so those of childbearing potential should be advised to use adequate contraception. Thyroid and hepatic function should be monitored. Cardiovascular related events: Common cases of bradycardia have been reported. Dose adjustments of drugs such as beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may be necessary. Gallbladder and related events: Cholelithiasis is a very common event during Sandostatin treatment and may be associated with cholecystitis and biliary duct dilatation. Cholangitis has been reported as a complication of cholelithiasis. Ultrasonic examination of the gallbladder before and at about 6-monthly intervals during therapy is recommended. Glucose metabolism: Sandostatin LAR may affect glucose regulation and induce hyper- or hypoglycaemia. It is recommended to monitor glucose tolerance and antidiabetic treatment. Patients with insulinomas should be closely monitored. Nutrition: Sandostatin LAR may alter absorption of dietary fats and vitamin B12. Monitoring of vitamin B12 levels is recommended during therapy in patients who have a history of vitamin B12 deprivation. Pancreatic function: pancreatic exocrine insufficiency has been seen in patients with GEP neuroendocrine tumours. Screening should be considered in symptomatic patients. Sodium content: Sandostatin LAR contains less than 1 mmol (23mg) sodium per vial, that is to say essentially “sodium-free”
Interactions: Impaired intestinal absorption of ciclosporin and cimetidine. Increased bioavailability of bromocriptine. Dose adjustment of medicinal products such as insulin and antidiabetics, beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance may be necessary. Somatostatin analogues may decrease the clearance of drugs metabolized by cytochrome P450 enzymes. Drugs metabolised by CYP3A4 with a low therapeutic index should be used with caution. Octreotide competitively binds to somatostatin receptors and may interfere with the efficacy of radioactive somatostatin analogues. Sandostatin LAR should be discontinued at least 4 weeks prior to the administration of lutetium (177Lu) oxodotreotide and can be resumed 4 to 24 hours afterwards. Short-acting somatostatin analogues may be used until 24 hours prior to administration of lutetium (177Lu) oxodotreotide.
Fertility, pregnancy and lactation: It is preferable to avoid the use of Sandostatin LAR during pregnancy. Patients should not breast-feed. It is not known whether octreotide has an effect on human fertility.
Undesirable Effects: Very Common (≥1/10): diarrhoea, abdominal pain, nausea, constipation, flatulence, headache, cholelithiasis, hyperglycaemia, injection site reactions. Common (≥1/100 to < 1/10): dyspepsia, vomiting, abdominal bloating, loose stools, steatorrhoea, discolouration of faeces, dizziness, hypothyroidism, thyroid disorder, cholecystitis, biliary sludge, hyperbilirubinaemia, hypoglycaemia, impairmed glucose tolerance, anorexia, asthenia, elevated transaminase levels, pruritus, rash, alopecia, dyspnoea and bradycardia. Uncommon (≥ 1/1000 to < 1/100): tachycardia, dehydration. Please refer to the SmPC for full details of all undesirable effects.
Pack Sizes: Packs containing one powder vial, one pre-filled glass syringe, one vial adapter and one safety injection needle.
Legal Category: Prescription Only Medicine
Product Authorisation Numbers:
Sandostatin LAR® 10 mg powder and solvent for suspension for injection PA0896/028/004
Sandostatin LAR® 20 mg powder and solvent for suspension for injection PA0896/028/005
Sandostatin LAR® 30 mg powder and solvent for suspension for injection PA0896/028/006
Product Authorisation Holder:
Novartis Ireland Limited
Vista Building,
Elm Park, Merrion Road,
Ballsbridge,
Dublin 4,
Ireland
Full prescribing information is available upon request from: Novartis Ireland Limited, Vista Building, Elm Park Business Park, Elm Park, Dublin 4. Tel: 01-2601255 or at www.medicines.ie Detailed information on this product is also available on the website of the European Medicines Agency http://www.ema.europa.eu
Prescribing information last revised: November 2021
Reporting suspected adverse reactions of the medicinal product is important to Novartis and the HPRA. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported via HPRA Pharmacovigilance, website www.hpra.ie. Adverse events could also be reported to Novartis preferably via www.report.novartis.com or by email: [email protected] or by calling 01 2080 612.
